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Planning and analysis of repeated measures at key time‐points in clinical trials sponsored by pharmaceutical companies
Author(s) -
Shih Weichung J.,
Quan Hui
Publication year - 1999
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/(sici)1097-0258(19990430)18:8<961::aid-sim83>3.0.co;2-i
Subject(s) - clinical trial , pharmaceutical industry , repeated measures design , computer science , plan (archaeology) , key (lock) , operations research , actuarial science , econometrics , management science , medicine , statistics , business , economics , mathematics , computer security , archaeology , pathology , pharmacology , history
In this paper we explore the possible reasons why medical papers reporting clinical trials sponsored by the pharmaceutical industry often analyse repeated measures data at certain key time‐points instead of employing sophisticated models of repeated measures proposed by many statisticians. A survey indicated that the priority reason in the industry for having repeated measures in clinical trials is to monitor the trial and to utilize the early results for strategic decision making. We discuss what the common statistical methods do and do not offer for analysis of repeated measures in such clinical trials. We advocate the need to improve the understanding of the medical interest in conducting longitudinal trials in the industry, and to plan and analyse the repeated measures accordingly. We address the medical interest by formulating the problem and give illustrative examples for both phases II and III trials. Copyright © 1999 John Wiley & Sons, Ltd.